DRUG DESCRIPTION

VISTIDE® is the brand name for cidofovir injection. The chemical name of
cidofovir is 1-[(S)-3-hydroxy-2-(phosphonomethoxy)propyl]cytosine dihydrate
(HPMPC), with the molecular formula of C8H14N3O6P•2H2O
and a molecular weight of 315.22 (279.19 for anhydrous). The chemical structure
is:

Cidofovir is a white crystalline powder with an aqueous solubility of ? 170 mg/mL at pH 6-8 and a log P (octanol/aqueous buffer, pH 7.1) value of -3.3.

VISTIDE (cidofovir) is a sterile, hypertonic aqueous solution for intravenous infusion
only. The solution is clear and colorless. It is supplied in clear glass vials,
each containing 375 mg of anhydrous cidofovir in 5 mL aqueous solution at a
concentration of 75 mg/mL. The formulation is pH-adjusted to 7.4 with sodium
hydroxide and/or hydrochloric acid and contains no preservatives. The appropriate
volume of VISTIDE (cidofovir) must be removed from the single-use vial and diluted prior
to administration (see DOSAGE AND ADMINISTRATION).

What are the possible side effects of cidofovir (Vistide)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

What are the precautions when taking cidofovir (Vistide)?

Before using cidofovir, tell your doctor or pharmacist if you are allergic to it; or to other antivirals (e.g., ganciclovir); or to probenecid; or to other sulfa drugs (e.g., sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

This drug may cause vision changes. Do not drive, use machinery, or...

Read All Potential Precautions of Vistide »

Vistide Consumer (continued)

SIDE EFFECTS: Nausea may occur. Headache, nausea, and vomiting may occur with probenecid use. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cidofovir, tell your doctor or pharmacist if you are allergic to it; or to other antivirals (e.g., ganciclovir); or to probenecid; or to other sulfa drugs (e.g., sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease.

This drug may cause vision changes. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at a greater risk for kidney damage while using this drug.

During pregnancy, cidofovir should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. The manufacturer recommends avoiding pregnancy. To prevent pregnancy, men with female partners should use effective barrier protections (such as latex or polyurethane condoms) during all sexual activity during treatment and for at least 90 days after stopping the medication. Women should use at least 2 forms of effective birth control (such as birth control pills and condoms) during treatment and for at least 1 month after stopping the medication.

It is not known if this medication passes into breast milk. Because of the possible risks to the infant and because breast milk can transmit HIV, do not breast-feed.

Vistide Patient Information Including Side Effects

Brand Names: Vistide

Generic Name: cidofovir (Pronunciation: si DOF o veer)

What is cidofovir (Vistide)?

What are the possible side effects of cidofovir (Vistide)?

What is the most important information I should know about cidofovir (Vistide)?

What should I discuss with my health care provider before receiving cidofovir (Vistide)?

How is cidofovir used (Vistide)?

What happens if I miss a dose (Vistide)?

What happens if I overdose (Vistide)?

What should I avoid while receiving cidofovir (Vistide)?

What other drugs will affect cidofovir (Vistide)?

Where can I get more information?

What is cidofovir (Vistide)?

Cidofovir is an antiviral medication that works by preventing certain viral cells from multiplying in your body.

Cidofovir is used to treat an eye infection called cytomegalovirus retinitis (CMV) in people who are infected with HIV (human immunodeficiency virus).

Cidofovir may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of cidofovir (Vistide)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cidofovir (Vistide)?

Do not receive this medication if you are allergic to cidofovir, probenecid (Benemid), or sulfa drugs, or if you have severe kidney disease.

Cidofovir may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Use an effective form of birth control while you are using cidofovir and for at least 1 month after your treatment ends.

Cidofovir can affect fertility (ability to have children) in men. If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 3 months after you stop using cidofovir.

Cidofovir must be used together with an oral (taken by mouth) medicine called probenecid (Benemid). Be sure to read the medication guide or patient instructions provided with each of your medications.

There are many other medicines that can interact with cidofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Cidofovir has caused certain types of tumors in animals. It is not known if humans would also have an increased risk of tumors. Talk with your doctor about your specific risk.